Bedwuine Senatus serves as the Quality and Regulatory Director at Medical Indicators, where he leverages over 14 years of extensive experience in engineering, research and development, and quality assurance within the highly regulated medical device sector. His expertise spans both Class 1 and Class 3...
Bedwuine Senatus serves as the Quality and Regulatory Director at Medical Indicators, where he leverages over 14 years of extensive experience in engineering, research and development, and quality assurance within the highly regulated medical device sector. His expertise spans both Class 1 and Class 3 medical devices, positioning him as a pivotal figure in ensuring compliance with stringent regulatory standards. Currently, Bedwuine is spearheading the transition to the European Union Medical Device Regulation (EU MDR) and the UK Medical Device Regulation (UK MDR), a critical initiative that safeguards the company’s ability to maintain CE and UKCA marking for existing products. This transition involves the development of comprehensive regulatory Standard Operating Procedures (SOPs) to ensure that all aspects of compliance are meticulously addressed.
In addition to his regulatory responsibilities, Bedwuine is instrumental in implementing an electronic Quality Management System (QMS) that encompasses essential quality system elements such as Change Control, Customer and Field Complaints, Corrective and Preventive Actions (CAPA), and Supplier Management. His leadership extends to managing a diverse team of engineers, quality technicians, and subject matter experts, fostering a collaborative environment that drives innovation and efficiency. Bedwuine’s proficiency in international regulations, coupled with his skills in software project management and post-market surveillance, enables him to prepare NAFTA documentation for customers in foreign markets, further enhancing the company’s global reach. With a solid foundation in ISO 14971 and stability studies, Bedwuine is committed to ensuring that Medical Indicators not only meets but exceeds industry standards, ultimately contributing to the safety and efficacy of medical devices in the marketplace.
